TEMPORARILY_NOT_AVAILABLENot Applicable

INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY

Plain-language summary

The expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform the assessment of outcomes, or (3) The trial site is not geographically accessible.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months)
✓. Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
✓. Disease characteristics: to be eligible, the participant must meet one criterion for obesity and at least one criterion for sarcopenia, as defined below:
✓. Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association)
✓. Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for
✓. No obesity, normal BMI women (World Health Organization)

Exclusion criteria

✕. Qualifying individuals by the current enrollment criteria that are in a 50-mile geographical radius of any IMM01-STEM clinical trial site or a potential clinical site.
✕. Inability to sign an informed consent
✕. Concomitant investigational drugs and treatments
✕. Concomitant medication included in the table 1.
✕. Current malignancy or recent malignancy in complete remission less than 3 years
✕. BMI \< 20
✕. Major surgical procedures in the past 30 days.
✕. Cognitive impairment, Alzheimer disease,

Trial details

NCT IDNCT06784297

SponsorImmunis, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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